Adaptive devices for securing medical articles

ABSTRACT

Adaptive medical article securement devices are described. These devices retain a medical article, for example, a catheter hub or a connector fitting, in position on a patient&#39;s body and reduce or inhibit longitudinal or other movement of the medical article. The securement device includes an adaptive retainer and at least one anchor pad used to attach the securement device to a patient&#39;s skin. The adaptive retainer is a flexible element that can adapt and conform to an exterior portion of the medical article to be secured, and in doing so forms a central channel in which at least a portion of the medical article becomes disposed. In some embodiments the retainer includes at least one engaging element that can engage a retention element disposed on the medical article. The engaging element, alone or in conjunction with the retention element and/or the shape (e.g., tapering) of the central channel, reduces or inhibits longitudinal motion of the medical article in the central channel.

RELATED APPLICATION

This application claims the benefit of and priority to now-expired U.S.provisional application Ser. No. 60/313,035, filed 11 Mar. 2010;commonly owned, published international PCT application serial numberPCT/US11/00461, filed 11 Mar. 2011; and commonly owned, co-pending U.S.National Stage under 35 USC 371 application, Ser. No. 13/320,025, filedon 10 Nov. 2011, and entitled ADAPTIVE DEVICES FOR SECURING MEDICALARTICLES, the contents of each application, which, where allowed, ishereby incorporated by reference in its entirety for any and allpurposes.

BACKGROUND OF THE INVENTION

1. Introduction

The following description includes information that may be useful inunderstanding the present invention. It is not an admission that anysuch information is prior art, or relevant, to the presently claimedinventions, or that any publication specifically or implicitlyreferenced is prior art.

2. Background

Modern medical practice frequently involves using catheters to introducefluids and medications directly into a patient's vasculature. Examplesinclude peripheral intravenous catheters (PIVCs) and central venouscatheters (CVCs). Often, it is necessary to maintain suchcatheterization over an extended period during a patient's treatment,particularly when the patient is hospitalized. In order to keep acatheter (or other medical line) properly positioned for as long asneeded, the catheter (or other medical line) is typically secured to thepatient in a variety of ways. Historically this involved taping thecatheter or medical line to the patient.

Securing catheters to patient using tape, however, has severaldrawbacks. First, the use of tape to secure a catheter can retain dirtor other contaminants at or near the catheter insertion site,potentially leading to infection or other complications. Indeed,numerous clinical studies have implicated improperly secured cathetersin a wide range of complications, including catheter-related bloodstream infections (CRBSI), of which there are about 80,000 annually inthe U.S. alone. Second, tape often fails to limit catheter movement inone or more directions, and thus can contribute to motion-relatedcomplications such as bruising, phlebitis, extravasation, infiltration,and catheter migration, which can lead to catheter dislodgement ordisconnection. Third, tape removal can itself cause undesired cathetermovement. Fourth, tape must periodically be changed, often daily. Thefrequent removal and reapplication of adhesive tape can irritate apatient's skin, as well as lead to the build up of adhesive residue onthe outer surface of the catheter (or other medical line). Such adhesiveresidue not only makes the catheter (or other medical line) stickier andmore difficult for healthcare providers to handle, it can also result incontaminants (including pathogens) adhering to the catheter itself,increasing the likelihood of infection, either at the skin surface orinternally. Fifth, tape securement can allow medical lines attached to acatheter to flex or kink, which can lead to clinical complications.

As a result of these drawbacks, other approaches to securing cathetersand medical lines have been sought. One such solution is reported inU.S. Pat. Nos. 7,014,627 and 7,799,001. However, such devices themselveshave many drawbacks, including high unit cost, the use of hard plasticcomponents (which can lead to patient discomfort), requirements forbulky packaging because of the device's awkward three-dimensional shape,difficulty in using such devices, and the need for hospitals to stocklarge inventories because individual devices are not adaptable to fitthe wide range of different catheters and medical articles routinely inuse today. For these reasons a significant unmet need still exists forinexpensive, low-profile, easy-to-use medical article securementdevices.

3. Definitions

Before describing the instant invention in detail, several terms used inthe context of the present invention will be defined. In addition tothese terms, others are defined elsewhere in the specification, asnecessary. Unless otherwise expressly defined herein, terms of art usedin this specification will have their art-recognized meanings.

The term “adaptive” refers a device's or structure's ability to adaptand substantially conform to the exterior shape and/or contours ofanother article, including articles having different exterior dimensionsand shapes.

A “medical article” refers to catheters, catheter hubs, medical lineconnector fittings, luer access devices, medical lines (e.g., tubingintended to deliver fluids to a patient), and the like.

A “patentable” composition, process, machine, or article of manufactureaccording to the invention means that the subject matter at issuesatisfies all statutory requirements for patentability at the time theanalysis is performed. For example, with regard to novelty,non-obviousness, or the like, if later investigation reveals that one ormore claims encompass one or more embodiments that would negate novelty,non-obviousness, etc., the claim(s), being limited by definition to“patentable” embodiments, specifically excludes the unpatentableembodiment(s). Also, the claims appended hereto are to be interpretedboth to provide the broadest reasonable scope, as well as to preservetheir validity. Furthermore, if one or more of the statutoryrequirements for patentability are amended or if the standards changefor assessing whether a particular statutory requirement forpatentability is satisfied from the time this application is filed orissues as a patent to a time the validity of one or more of the appendedclaims is questioned, the claims are to be interpreted in a way that (1)preserves their validity and (2) provides the broadest reasonableinterpretation under the circumstances.

A “plurality” means more than one.

SUMMARY OF THE INVENTION

The devices and methods of the present invention have several features,no single one of which is solely responsible for its desirableattributes. Without limiting the scope of this invention as expressed bythe appended claims, its more prominent features will now be summarized.After considering this summary, and particularly after reading thesection entitled “Detailed Description of the Invention's PreferredEmbodiments,” one will understand how the features of this inventionprovide several advantages over conventional catheter securementapproaches.

One aspect of the invention relates to adaptive medical articlesecurement devices. Such devices include an adaptive retainer having afirst anchor region spaced from a second anchor region by a flexible,preferably segmented, substantially flat substrate configured to deformto form a central channel about a channel axis upon application of adeforming force. To form the central channel, the flexible, preferablysegmented, substantially flat substrate of the adaptive retainerincludes a flexible channel forming element, which is preferablycomprised of “n” (where “n” is an integer not less than 2) spacedchannel hinge elements that define n−1 channel forming segments. Thechannel hinge elements preferably are living hinges. In embodiments thatemploy channel hinge elements, the segmented, substantially flatsubstrate also preferably includes first and second channel boundaryhinge elements (preferably also living hinges) between which theplurality of spaced channel hinge elements are disposed, which thencombined with the spaced channel hinge elements define n+1 channelforming segments. Preferably, the channel boundary hinge elements andchannel hinge elements are principally located on opposite sides of thesubstrate, usually with the channel hinge elements being located on thesubstrate's upper surface and the channel boundary hinge elements beinglocated on the opposite, lower surface of the substrate.

As those in the art will appreciate, deforming the adaptive retainerforms the central channel. This can be accomplished by applying adeforming force to the adaptive retainer. Preferably, the medicalarticle one wishes to retain or secure is present, and preferably usedin the deforming process, although this is not required, particularly inthe context of embodiments where the adaptive retainer is designed todeform to form a central channel of predetermined size and shape. Whenthe medical article is present, the segmented, substantially flatsubstrate can be associated with a desired portion of the medicalarticle so that upon application of the deforming force the adaptivearticle's substrate forms a central channel that retainingly engages themedical article.

The central channel, when formed, may be closed (i.e., the centralchannel has an arc length of 360 degrees) or open (i.e., the centralchannel has an arc length of less than 360 degrees, and preferably morethan 180 degrees). The central channel also has a distal opening and aproximal opening, and is configured to engage at least a portion of amedical article inserted therein in order to retain the medical article.In preferred embodiments, the central channel, once formed, has atapered shape. Preferably, the tapered shape of the central channel isdesigned to complement a cooperatively tapered shape of that portion ofthe medical article to be secured by the device according to theinvention.

In some embodiments, the lower (i.e., skin-facing) surface of each ofthe first and second anchor regions is coated with an adhesive designedto attach to the device an epidermal layer of a patient. In preferredembodiments, the adhesive coatings are covered by a removable layer thatcan easily be peeled away or otherwise removed just prior to adheringthe device to a desired location on a patient's body. In otherembodiments, the adaptive retainer is connected to at least one anchorpad having a lower adhesive surface configured to attach to an epidermallayer of a patient and an upper surface at least a portion of which canbe adhered to the first and second anchor regions of the adaptiveretainer.

In certain preferred embodiments, the adaptive medical articlesecurement devices of the invention also include at least one engagingelement configured to engage a retention element disposed on the surfaceof the medical article to be secured. The combination of such engagingand retention elements serves to reduce or inhibit movement of themedical article once the securement devices is attached or otherwiseadhered to the patient. The sorts of movement that can be inhibited orreduced include longitudinal movement of the medical article in relationto central axis of the central channel, as well pitch, roll, and/or yawof the medical article in relation to the securement device.

A related aspect of the invention concerns medical article securementsystems. Such systems include an adaptive medical article securementdevice according to the invention and a medical article retained in thecentral channel thereof.

Still other aspects of the invention relate to various methods of usingthe instant adaptive medical article securement devices. Such methodsinclude uniting medical articles with complementary adaptive medicalarticle securement devices by deforming such a securement device, beforeor (preferably) after association with a medical article so that thecentral channel of the securement device can retainingly engage themedical article. Still other methods involve securing a medical articleto a patient using an adaptive medical article securement deviceaccording to the invention. Typically such methods are accomplished byuniting a medical article with an adaptive medical article securementdevice and adhering the device's anchor pad(s) to the patient's skin.

Other aspects, embodiments, features, and advantages of the inventionwill be apparent from the following drawings, detailed description, andappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of a representative adaptive medical articlesecurement device according to the invention prior to being adapted toreceive a medical article.

FIG. 1B is a side view of the securement device shown in FIG. 1A afterbeing adapted to receive a medical article.

FIG. 1C is a plan view of the securement device shown in FIG. 1A.

FIG. 2A shows the securement device in a substantially planarconfiguration.

FIG. 2B shows the device after it has been folded to form a centralchannel

FIG. 3A is a representative cross-sections, of a “living hinge”, apreferred flex or hinge element useful in practicing the invention.

FIG. 3B shows a representative cross-sections, of a “living hinge”, apreferred flex or hinge element useful in practicing the invention.

FIG. 3C shows another representative cross-sections, of a “livinghinge”, a preferred flex or hinge element useful in practicing theinvention.

FIG. 4A is analogous to that shown in FIG. 10. In this embodiment,however, the anchor regions comprise a plurality of perforations thatextend through the adaptive retainer's substrate.

FIG. 4B shows an alternative embodiment of a securement device.

FIG. 5A shows an alternative embodiment of a securement device thatincludes a adaptive retainer.

FIG. 5B shows an alternative embodiment of a securement device that issimilar to the embodiment depicted in FIG. 5A of the figure, thedifference being that in the embodiment shown in FIG. 5B, the adaptiveretainer includes a slot-shaped engaging element.

DETAILED DESCRIPTION OF THE INVENTION'S PREFERRED EMBODIMENTS

The following description and the accompanying drawings, which describeand show the preferred embodiments, demonstrate several possiblerepresentative configurations that an adaptive medical articlesecurement device can take to include various aspects and features theinvention. The illustrated embodiments are shown in use with either oneor both of an illustrative example of a catheter hub and an illustrativeexample of a luer access device and extension set connected to thecatheter hub. These illustrations are not intended to limit theinvention to the specified embodiments or usage. Those skilled in theart will recognize that the described aspects and features of theinvention are not limited to any particular embodiment of a securementdevice, and securement devices according to the invention can readily bedesigned for use with a variety of medical articles.

To assist in the description of the invention, the following coordinateterms are used. A “longitudinal axis” is generally parallel to a portionof the catheter hub, the connector fitting or other medical articleretained by the an adaptive medical article securement device of theinvention, as well as parallel to the axis of the central channel of theadaptive retainer, through which the medical article extends. A “lateralaxis” is normal or perpendicular to the longitudinal axis. In addition,“longitudinal direction” refers to a direction substantially parallel tothe longitudinal axis and “lateral direction” refers to a directionsubstantially parallel to the lateral axis. The term “axial” refers tothe axis of the central channel or connector fitting, and therefore issubstantially synonymous with the term “longitudinal” as used herein.Also, the terms “proximal” and “distal”, are used consistently, and incontext refer to near and far, respectively. The terms “upper,” “lower,”“top,” “bottom,” “underside,” “upperside” and the like, are used inreference to the orientation of the particular embodiment.

The preferred embodiments of the present invention advantageouslyprovide a adaptive medical article securement device for securing amedical article to a patient. The medical article preferably has anelongated body that cooperates with the adaptive retainer to arrestmovement of the medical article in longitudinal, lateral, and otherdirections when placed within the retainer.

This invention concerns a patentable new generation of patentableadaptive devices for securing medical articles (e.g., medical lines,needles, catheters, etc.) to a patient's skin. Such devices include anadaptive retainer and at least one anchor pad. A medical grade film mayalso be included. The adaptive securement devices of the invention canbe readily adapted to fit a wide range of medical article types,combinations, and dimensions for easy, rapid, and secure attachment to apatient's skin. They are also inexpensive and efficient to manufactureand, because of the adaptive nature of the retainer element, whenpackaged each device requires minimal storage space. Finally, theadaptive nature of the retainer element makes them easy to use to securea medical article.

The flexible, adaptive retainer includes a flexible, optionallysegmented, substantially flat substrate disposed between two anchorregions. The substrate incorporates one or more flex elements or hinges(e.g., partial kerfs, grooves, depressions, perforations, and the like)on at least its upper surface (i.e., the surface of the substrate facingaway from a patient's skin) and two or more flex elements or hinges onits lower surface (i.e., the substrate's surface facing toward apatient's skin) that allow the initially substantially flat or planarsubstrate of the adaptive retainer to be bent, molded, folded, orotherwise shaped to conform the external structure(s) of the medicalarticle to be secured when the securement device is brought into contactthe medical article(s). The flex elements on the upper surface allow thesecurement device to be readily adapted to the particular shape andgeometry of the external structure of the medical article(s) to besecured. The portion of the adaptive retainer intended for contact orother secure association with a medical article constitutes a medicalarticle contact region, which is disposed in the flexible, optionallysegmented, substrate portion of the adaptive retainer. Preferably, theflexible substrate portion contains the at least one flex element on itsupper surface. The flexible substrate portion is typically bounded oneither end by at least one flex element or hinge located on the lowersurface of the adaptive retainer. In many embodiments, the flex elementsor hinges on the upper surface are located between the flex element(s)or hinges on the lower surface on either side of the device contactregion. In some embodiments, flex elements are found opposite each otheron the upper and lower surfaces of at least part of the device. In otherembodiments, one or flex elements are not disposed on a surface of thesubstrate but are disposed within its interior.

In each of the embodiments described below, the adaptive retainer has aflexible, preferably segmented, substantially flat substrate that isdeformed to form a central channel. The central channel has a distalopening to allow insertion and withdrawal the medical article to besecured. The medical article is installed or removed from the adaptiveretainer via this distal opening. Such an arrangement allows a healthcare provider to align at least a portion of the medical article withthe adaptive retainer before fixing the device to the patient's skin. Inthis way, the adaptive retainer's central channel retains a portion ofthe medical article.

The adaptive retainer preferably includes at least one engaging elementthat cooperates with at least one retention element on the medicalarticle. The one or more engaging elements of the adaptive retainerpreferably are disposed normal to the axis of the central channel andcan be, for example, a slot, a hole, or like structures. The engagingelement cooperates with the one or more retaining elements disposed onthe surface of the medical article to inhibit movement of the medicalarticle through or in the channel. For example, the engaging elementcould be a slot in the substrate disposed to engage at least a portionof a radially extending ridge, post, or other structure protruding fromsurface of the medical article. In this way, the medical article islimited in longitudinal movement (i.e., movement toward the patient)once the radially extending retaining element engages the slot in theadaptive retainer.

The adaptive retainer of each embodiment described below furtherincludes two anchor regions disposed at opposite ends of the flexiblesubstrate. When adapted to conform to a portion of medical article'sexterior surface, the adaptive retainer holds the retained portion ofmedical article away from the patient's skin, when the retained portionis positioned within the central channel of the adaptive retainer, toavoid chaffing or excoriating tile skin. In some preferred embodiments,the articles also include a removal tab disposed at one or both ends ofthe anchor regions (or anchor pad) to allow for the securement device'seasy removal from a patient's skin. Removal tabs typically do notinclude an adhesive.

The adaptive retainer and anchor regions also can have otherconstructions to minimize contact between the patient's skin and theadaptive retainer, as well as between the patient and the retainedportion of the medical article. For example, the anchor pads can bethicker, in which case the mounting wings can be located higher on theretainer body.

In embodiments have at least two anchor regions, the anchor regions arepreferably disposed opposite each other at or near the distal ends ofthe adaptive retainer and spaced by the flexible, adaptive substrate.The anchor regions also have an adhesive located on the surface intendedfor skin contact. The adhesive should be suitable for securing thearticle to a patient and for prolonged skin contact (i.e., for more thanone hour, up to and including 1, 3, 5, or more days).

In order to protect the adhesive characteristics of the anchor regions,the securement devices of the invention are manufactured to include aremovable layer attached to those surfaces to which an adhesive layerhas been applied. Just prior to use the removable layer(s) can beseparated from (e.g., by peeling) the rest of the device, after whichthe removable layer(s) can be disposed of.

In some preferred embodiments, the articles are substantially planarwhen packaged, allowing for easy, dense packaging as single,individually packaged, preferably sterile, articles.

The securement devices of the invention include an adaptive retainerthat can readily conform, or adapt, to the exterior shape of a medicalarticle to be retained. The adaptive retainer is flexible in nature, dueboth in part to its structure and to the material used to form it.Suitably flexible, non-segmented materials include various natural andsynthetic rubbers and soft plastics. For embodiments that employsegmented adaptive retainer, for example, when the segments areconnected by flex elements such as living hinges, suitable materialsinclude, for example, plastics, polymers or composites such aspolypropylene, polyethylene, polycarbonate, polyvinylchloride,acrylonitrile butadiene styrene, nylon, olefin, acrylic, polyester, aswell as moldable silicon, thermoplastic urethane, thermoplasticelastomers, thermoset plastics, and the like. However, any material canbe utilized.

The securement devices of the invention are preferably integrally formedto comprise a unitary retainer.

This can be accomplished in any of a variety of ways well known to thoseskilled in the art. For instance, the entire device can be injectionmolded in order to reduce fabrication costs. The devices, however, cancomprise non-unitary construction, for example, by joining independentlymanufactured adaptive retainers and anchor regions or anchor pads.

To facilitate a complete understanding of the invention, the remainderof the detailed description describes adaptive medical articlesecurement devices by reference to the drawings, wherein like elementsamong the embodiments are referenced with like numerals throughout thefollowing description.

FIGS. 1A-1C show three views of an adaptive medical article securementdevice (100). FIG. 1A shows a side view of the securement device (100).The device has two anchor regions (101, 102) spaced apart by a flexible,substantially planar substrate (103) configured to deform to form acentral channel (110) about a channel axis (112) upon application of adeforming force (not shown). In this embodiment, the substrate'sflexibility is provided by several flex or hinge elements (1-11) thatsegment the substrate. Hinge elements 1-9 provide the capacity for thesubstrate to be deformed or folded into ten segments to retain a medicalarticle by applying a deforming force to form a central channel (110).Hinge elements 10 and 11 demarcate the boundaries between the flexiblesubstrate and the anchor regions (101, 102). The lower, or bottom,surface of each anchor region (101, 102) is coated with an adhesive(104) suited to attach the securement device to a patient's skin. FIG.1B shows the securement device after application of a deforming force,which results in the flexible substrate being folded to form an opencentral channel (110) comprised of 10 segments about a channel axis(112). FIG. 10 shows a plan view of the securement device (100) of FIG.1A.

FIG. 2A and FIG. 2B show views of an adaptive medical article securementdevice (100) that has a flexible, segmented substrate (103). FIG. 2Ashows the securement device in a substantially planar configuration.FIG. 2B shows the device after it has been folded to form a centralchannel (110) to receive a medical article (not shown). In thisembodiment, hinge elements 1-10, 20, and 21 provide the capacity for thesubstrate to be deformed or folded into eleven segments to retain amedical article by applying a deforming force to form the centralchannel.

FIG. 3A, FIG. 3B, and FIG. 3C show three representative cross-sections,of a “living hinge”, a preferred flex or hinge element useful inpracticing the invention. A living hinge is a thin, flexible hinge (aflexure bearing, 120) made from plastic that joins two rigid plasticparts (121, 122) together, allowing the plastic to bend in relation toeach other along the line of the hinge (not shown). Living hinges aretypically made in an injection molding process that creates all of theparts at one time as a single part. Polypropylene and polyethylene areparticularly preferred plastics for fabricating parts with livinghinges, such as adaptive retainers according to the invention. Thethinned section (120) of the part allows for movement of the adjacentrigid plastic parts (121, 122) about the hinge line.

FIG. 4A and FIG. 4B show two panels. The securement device shown in FIG.4A is analogous to that shown in FIG. 1C. In this embodiment, however,the anchor regions (101, 102) comprise a plurality of perforations (131)that extend through the adaptive retainer's substrate. FIG. 4B shows analternative embodiment of a securement device (200) that includes aadaptive retainer that has first and second anchors (201, 202) and aflexible substrate (203) with a plurality of hinge elements (1-11), nineof which are on the upper surface of the flexible substrate (203) andtwo of which (10, 11) are on the lower surface of the flexible substrate(203). Attached to the adaptive retainer via hinge region (40) is ananchor pad (210). When adaptive retainer and anchor pad (210) are foldedabout their joining hinge (40), preferably after adapting the adaptiveretainer to mate with a medical article (e.g., a catheter hub) the uppersurfaces of the first and second anchors (201, 202) of the adaptiveretainer can be attached, preferably using an adhesive coated onto theupper surface of each of the first and second anchors (201, 202), to theupper surface (211) of the anchor pad (210). The anchor pad can then beused to attach the securement device to a patient's skin, preferablyusing a biocompatible adhesive coated on the lower surface (212) of theanchor pad (210).

FIG. 5A and FIG. 5B show two panels. FIG. 5A shows an alternativeembodiment of a securement device (300) that includes a adaptiveretainer that has first and second anchors (301, 302) and a flexiblesubstrate (303) with a plurality of hinge elements (1-12), ten of which(1-10) are on the upper surface of the flexible substrate (303) and twoof which (11, 12) are on the lower surface of the flexible substrate(303). In this embodiment, the hinge elements are not substantiallyparallel to one another; instead, their separation (X) at the leadingedge (304) of the flexible substrate (303) is less than their separationat the trailing edge (305) of the flexible substrate (303). As a result,when the flexible substrate is deformed so as to become adapted toreceive or engage a medical article, a tapered central channel is formedsuch that the distal opening of the central channel in such anembodiment is larger than the proximal opening. As those in the art willappreciate, such configurations are well suited for engaging medicalfittings that have tapered exterior surfaces.

FIG. 5B shows an alternative embodiment of a securement device (350)that is similar to the embodiment depicted in FIG. 5A of the figure, thedifference being that in the embodiment shown in FIG. 5B, the adaptiveretainer includes a slot-shaped engaging element (360) configured toengage a retention element (not shown) disposed on the surface of amedical article (not shown) so as to reduce or inhibit movement,optionally longitudinal and/or pitch and/or roll and/or yaw movement, ofa medical article retainingly engaged by the adaptive retainer.

All of the devices, articles, systems, and methods described and claimedherein can be made and executed without undue experimentation in lightof the specification and drawings. While the invention has beendescribed in terms of preferred embodiments, it will be apparent tothose of ordinary skill in the art that variations may be applied to thedevices, articles, systems, and methods without departing from thespirit and scope of the invention. All such variations and equivalentsapparent to those skilled in the art, whether now existing or laterdeveloped, are deemed to be within the spirit and scope of the inventionas defined by the appended claims.

All patents, patent applications, and publications mentioned in thespecification are indicative of the levels of those of ordinary skill inthe art to which the invention pertains. All patents, patentapplications, and publications are herein incorporated by reference intheir entirety for all purposes and to the same extent as if eachindividual publication was specifically and individually indicated to beincorporated by reference in its entirety for any and all purposes.

The invention illustratively described herein suitably may be practicedin the absence of any element(s) not specifically disclosed herein.Thus, for example, in each instance herein any of the terms“comprising”, “consisting essentially of”, and “consisting of” may bereplaced with either of the other two terms. The terms and expressionswhich have been employed are used as terms of description and not oflimitation, and there is no intention that in the use of such terms andexpressions of excluding any equivalents of the features shown anddescribed or portions thereof, but it is recognized that variousmodifications are possible within the scope of the invention claimed.Thus, it should be understood that although the present invention hasbeen specifically disclosed by preferred embodiments and optionalfeatures, modification and variation of the concepts herein disclosedmay be resorted to by those skilled in the art, and that suchmodifications and variations are considered to be within the scope ofthis invention as defined by the appended claims.

What is claimed is:
 1. An adaptive medical article securement deviceselected from the group consisting of, comprising: a. an adaptivemedical article securement device that comprises an adaptive retainer,wherein the adaptive retainer comprises a first anchor region spacedfrom a second anchor region by a flexible, optionally segmented,substantially flat substrate configured to deform to form a centralchannel about a channel axis upon application of a deforming force, thecentral channel (i) comprising a distal opening and a proximal openingand (ii) being configured to engage at least a portion of a medicalarticle inserted into the central channel so as to retain the medicalarticle, wherein a lower. surface of each of the first and second anchorregions comprise an adhesive configured to attach to an epidermal layerof a patient, wherein the adhesive optionally is covered by a removablelayer; and b. an adaptive medical article securement device thatcomprises an adaptive retainer connected to at least one anchor pad,wherein: (i) the adaptive retainer comprises a first anchor regionspaced from a second anchor region by a segmented, substantially flatsubstrate configured to deform to form a central channel about a channelaxis upon application of a deforming force, the central channel (A)comprising a distal opening and a proximal opening and (B) beingconfigured to engage at least a portion of a medical article insertedinto the central channel so as to retain the medical article; and (ii)the at least one anchor pad comprises (A) a lower adhesive surfaceconfigured to attach to an epidermal layer of a patient and (B) an uppersurface at least a portion of which can be adhered to the first andsecond anchor regions.
 2. An adaptive medical article securement deviceaccording to claim 1 wherein the segmented, substantially flat substratecomprises a first plurality (n) of spaced channel hinge elements thatdefine a second plurality (n−1) of channel forming segments.
 3. Anadaptive medical article securement device according to claim 2 whereinthe segmented, substantially flat substrate comprises first and secondchannel boundary hinge elements between which the plurality of spacedchannel hinge elements are disposed.
 4. An adaptive medical articlesecurement device according to claim 3 wherein the plurality of spacedchannel hinge elements are principally disposed on an upper surface ofthe segmented, substantially flat substrate and the first and secondchannel boundary hinge elements are principally disposed on a lowersurface of the segmented, substantially flat substrate.
 5. An adaptivemedical article securement device according to claim 1 that furthercomprises at least one engaging element configured to engage a retentionelement disposed on the surface of the medical article so as to reduceor inhibit movement, optionally longitudinal and/or pitch and/or rolland/or yaw movement of the medical article.
 6. An adaptive medicalarticle securement device according to claim 1 wherein the portion ofthe medical article engaged by the central channel is a catheter hub orconnector fitting, optionally a luer access device.
 7. An adaptivemedical article securement device according to claim 1 wherein thecentral channel has an arc length of greater than 180 degrees.
 8. Anadaptive medical article securement device according to claim 1 whereinthe central channel, once formed, has a tapered shape, wherein thetapered shape of the central channel, once formed, is configured tocomplement a cooperative tapered shape of the portion of the medicalarticle to be disposed in the central channel.
 9. A medical articlesecurement system, comprising: a. an adaptive medical article securementdevice according to claim 1; and b. a medical article retained in thecentral channel of the adaptive medical article securement device.
 10. Amethod of uniting a medical article with an adaptive medical articlesecurement device, comprising deforming an adaptive medical articlesecurement device according to claim 1 about at least a portion of amedical article so that the central channel of the adaptive medicalarticle securement device retainingly engages the portion of a medicalarticle, thereby uniting the medical article with the adaptive medicalarticle securement device.
 11. A method of securing a medical article toa patient, comprising uniting a medical article with an adaptive medicalarticle securement device according to claim 7 and adhering the anchorpad(s) to a patient's skin.